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The purpose of this study is to determine if the addition of acupuncture to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.
Investigators are studying whether a specific acupuncture protocol, when added to the standard of care treatment, can improve pain and function in adults with plantar fasciosis. Investigators hypothesize that there will be a significant improvement in both pain and functional outcomes, both acutely and over time, in the experimental group compared to the control group. Investigators will measure foot pain immediately prior to treatment (baseline), immediately after the initial treatment and at 2 weeks, 4 weeks, and 3 months. The Foot Function Index Revised short form will be used during the same intervals to evaluate foot function. At 3 months, patients in the non-acupuncture group will cross-over into the acupuncture group if still experiencing pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture | Active Comparator | Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. |
|
| Standard of Care | Experimental | The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. |
|
| Crossover | Experimental | At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupunture | Device | acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| NPRS-11 | Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| FFI-R | Revised Foot Function Index Short Form. FFI-R measures the impact of foot pathology on function for 5 subscales of: pain (7 questions), stiffness (7 questions), difficulty (11 questions), activity limitation (3 questions), social issues (6 questions). Each question ranges from 1 (no pain/no stiffness/no difficulty/none of the time) to 4 (severe pain/stiffness/difficulty/all of the time). Subscale scores are added up to a total cumulative score. Minimum total score (least pain/stiffness/difficulty) is 34. Maximum total score (most pain/stiffness/difficulty) is 136. |
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THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion Criteria:
Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with plantar fasciitis/fasciosis OR Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning & tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts). Those with acute and chronic diagnoses will be included.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cagle, MD | Scott AFB | Principal Investigator |
| Carlton Covey, MD | Nellis AF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scott AFB | Belleville | Illinois | 62225 | United States | ||
| Mike O'Callaghan Federal Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20807448 | Background | Cotchett MP, Landorf KB, Munteanu SE. Effectiveness of dry needling and injections of myofascial trigger points associated with plantar heel pain: a systematic review. J Foot Ankle Res. 2010 Sep 1;3:18. doi: 10.1186/1757-1146-3-18. | |
| 24080555 | Background | Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71. |
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94 total subjects. 78 total subjects analyzed. 39 from the initial placebo group were allowed to crossover once their placebo study role was completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acupuncture | Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
| FG001 | Standard of Care | The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Standard of care: standard of care home exercise program |
| FG002 | Crossover | At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomized |
| |||||||||||||
| Crossover to Acupuncture |
|
39 of the 47 Standard of care crossed over.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acupuncture | Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | NPRS-11 | Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain. | Crossover pulls from the standard of care group. There are not 30 additional subjects, merely 30 subjects pulled from standard of care to crossover to acupuncture group. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
90 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acupuncture | Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non Serious Adverse Event | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Crawford | MOMH | 7026533583 | amanda.j.crawford.ctr@health.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 24, 2019 | Jan 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Other | standard of care home exercise program |
|
| 90 days |
| Nellis Air Force Base |
| Nevada |
| 89191 |
| United States |
| 25682385 | Background | Glickman-Simon R, Wallace J. Acupuncture for knee osteoarthritis, chasteberry for premenstrual syndrome, probiotics for irritable bowel syndrome, yoga for hypertension, and trigger point dry needling for plantar fasciitis. Explore (NY). 2015 Mar-Apr;11(2):157-61. doi: 10.1016/j.explore.2014.12.009. Epub 2014 Dec 29. No abstract available. |
| 23227789 | Background | Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863. |
| 25114704 | Background | Li S, Shen T, Liang Y, Zhang Y, Bai B. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up. Evid Based Complement Alternat Med. 2014;2014:164714. doi: 10.1155/2014/164714. Epub 2014 Jul 8. |
| 25102533 | Background | Schwartz O, Levinson T, Astman N, Haim L. Attrition due to orthopedic reasons during combat training: rates, types of injuries, and comparison between infantry and noninfantry units. Mil Med. 2014 Aug;179(8):897-900. doi: 10.7205/MILMED-D-13-00567. |
| 26535232 | Background | Owens BD, Wolf JM, Seelig AD, Jacobson IG, Boyko EJ, Smith B, Ryan MA, Gackstetter GD, Smith TC; Millennium Cohort Study Team. Risk Factors for Lower Extremity Tendinopathies in Military Personnel. Orthop J Sports Med. 2013 Jun 11;1(1):2325967113492707. doi: 10.1177/2325967113492707. eCollection 2013 Jan-Jun. |
| 21882780 | Background | Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006. |
| 19952249 | Background | Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257. |
| 27526703 | Background | Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16. |
| 25892707 | Background | Woitzik E, Jacobs C, Wong JJ, Cote P, Shearer HM, Randhawa K, Sutton D, Southerst D, Varatharajan S, Brison RJ, Yu H, van der Velde G, Stern PJ, Taylor-Vaisey A, Stupar M, Mior S, Carroll LJ. The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):633-45. doi: 10.1016/j.math.2015.03.012. Epub 2015 Mar 28. |
| 19933769 | Background | Zhang SP, Yip TP, Li QS. Acupuncture treatment for plantar fasciitis: a randomized controlled trial with six months follow-up. Evid Based Complement Alternat Med. 2011;2011:154108. doi: 10.1093/ecam/nep186. Epub 2011 Feb 15. |
| NOT COMPLETED |
|
| BG001 |
| Standard of Care |
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Standard of care: standard of care home exercise program |
| BG002 | Crossover | At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| foot injury history | Number | participants |
|
| Standard of Care |
The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Standard of care: standard of care home exercise program |
| OG002 | Crossover | At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. |
|
|
| Secondary | FFI-R | Revised Foot Function Index Short Form. FFI-R measures the impact of foot pathology on function for 5 subscales of: pain (7 questions), stiffness (7 questions), difficulty (11 questions), activity limitation (3 questions), social issues (6 questions). Each question ranges from 1 (no pain/no stiffness/no difficulty/none of the time) to 4 (severe pain/stiffness/difficulty/all of the time). Subscale scores are added up to a total cumulative score. Minimum total score (least pain/stiffness/difficulty) is 34. Maximum total score (most pain/stiffness/difficulty) is 136. | Crossover pulls from the standard of care group. There are not 30 additional subjects, merely 30 subjects pulled from standard of care to crossover to acupuncture group. | Posted | Mean | Standard Deviation | score on a scale | 90 days |
|
|
|
| 0 |
| 47 |
| 0 |
| 47 |
| 4 |
| 47 |
| EG001 | Standard of Care | The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises. Standard of care: standard of care home exercise program | 0 | 47 | 0 | 47 | 1 | 47 |
| EG002 | Crossover | At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study. Acupunture: acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed. | 0 | 39 | 0 | 39 | 0 | 39 |
| Non Serious Adverse Event | Gastrointestinal disorders | Non-systematic Assessment |
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| week 2 |
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| week 4 |
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| week 6 |
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| week 12 |
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